BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA CH CANNULATED HAMMERTOE SYSTEM

    MDR report key: 16299616 · Received February 3, 2023

    Report

    Report Number
    3009540749-2023-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 3, 2022
    Report Date
    February 3, 2022
    Manufacturer
    MEDARTIS INC
    Product Code
    HWC
    PMA / PMN Number
    K221610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDTIONAL INFORMATION IS PROVIDED THAT CHANGES THE OUTCOME OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MID IMPLANT SHOULD PUT INTO PROX IMPLANT AND HAVE A FRICTION FIXATION. THERE WAS NOT ENOUGH FIXATION FOR THE IMPLANTS TO STAY TOGETHER. THE SURGEON TRIED A LARGER MID IMPLANT. SAME RESULT. SO SURGEON REMOVED IMPLANTS TO RETURN TO ZB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114170 NEXTRA CH CANNULATED HAMMERTOE SYSTEM SCREW HWC MEDARTIS INC 168101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CH-35M LOT 1574804| CH-425M 1574805